Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)

• Status: Completed
• Trial end date: 2020-07-20
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as Crohn's disease activity index (CDAI) < 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Collaborator: Galapagos NV

Criteria

Key Inclusion Criteria:

• Males or non-pregnant, nonlactating females, ages 18 to 75 years, inclusive based on the date of screening visit

• Moderately or severely active CD

• Minimum duration of CD of at least 6 months

• Presence of diseased small bowel (SB) segments in at least 1 of the following segments: terminal ileum, distal ileum, or jejunum

• Patients with additional colonic involvement of CD are permitted in study as long as SBCD is present

• Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines):

• Corticosteroids

• Immunomodulators

• Tumor necrosis factor-alpha (TNFα) antagonists

• Vedolizumab

• Ustekinumab

• Willing and able to undergo magnetic resonance enterography (MRE) per protocol requirements

Key Exclusion Criteria:

• Presence of symptomatic or clinically significant (eg, obstructive or symptomatic) strictures or stenosis.

• Presence of fistulae

• Evidence of short bowel syndrome

• Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon

• History of total colectomy, subtotal-colectomy, presence of ileostomy or colostomy, or likely requirement for surgery during the study

• Use of any prohibited concomitant medications as described in the study protocol

• Active tuberculosis (TB) or history of latent TB that has not been treated

Note: Other protocol defined Inclusion/Exclusion criteria may apply.